Cleared Traditional

KITS AND TRAYS FOR ONE TIME USE ONLY (K903963) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K903963 · Apk Technology · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
335d
Days
Class 1
Risk

K903963 is an FDA 510(k) clearance for the KITS AND TRAYS FOR ONE TIME USE ONLY. Classified as Tray, Surgical (product code LRP), Class I - General Controls.

Submitted by Apk Technology (Israel, IL). The FDA issued a Cleared decision on July 29, 1991 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Apk Technology devices

Submission Details

510(k) Number K903963 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received August 28, 1990
Decision Date July 29, 1991
Days to Decision 335 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 115d · This submission: 335d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRP Tray, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.